Status of GMOs and Products
Healthcare Applications
Under Clinical Trials
List of recombinant pharmaceutical/therapeutic products  recommended by RCGM for clinical trials to be conducted with the permission of Drug Controller General of India

S.No.

Product

  YEAR 2013
107
human Granulocyte Colony Stimulating Factor rH-GCSF (Filgrastim)
106
human Insulin analog B28asp (ASPART)
105
Rituximab
  YEAR 2012
104
PEG-Interferon alpha 2b
103
Ranibizumab
102
Trastuzumab
101
Pneumococcal Conjugate Vaccine formulation I
100
Granulocyte Colony Stimulating Factor (r-GCSF)
99
Bevacizumab
98
Rabies G VLP vaccine
97
Rituximab (Mab-2)
96
Human Interferon Alpha 2a (IFN-Alpha 2a)
95
Pegylated human Granulocyte Colony Stimulating Factor (pegylated rhG-CSF)
94
Adalimumab
93
Interleukin 11 (rhIL11)
92
TNFR:Fc fusion protein (Etanercept)
  YEAR 2011
91
H1N1-09 Influenza VLP (Virus Like Particles) Vaccine manufactured indigenously
90
Clot Specific Streptokinase
89
Infliximab-monoclonal antibody
88
Enfuvirtide internally coded as VB 20
87
MAB-1, Trastuzumab
86
Parathyroid hormone (rh-PTH 1-34)
85
Rituximab
84
Bevacizumab-monoclonal antibody
83
Trastuzumab-monoclonal antibody
82
Live recombinant vaccine of Vibrio cholerae VA 1.4
81
Filgrastim (rDNA origin) Injection (300mcg/vial)
80
Pegylated Erythropoietin
79
Darbopoetin alfa
78
Pegylated GCSF
  YEAR 2010
77
Somatropin (rhGH)
76
Bmab100 monoclonal antibody
75
Pegylated recombinant human erythropoietin (PEGEPO)
74
Polysialylated erythropoietin
73
Anthrax vaccine
72
Peg-Interferon alfa-2b
71
Follitropin alfa (Follicle Stimulating Hormone)
70
rh-GCSF (Filgrastim)
69
BVX20 monoclonal antibody
68
Insulin-Aspart R and Insulin-Aspart 30/70
67
Rituximab-monoclonal antibody
66
Chimeric monoclonal antibody (IgG1k) Abciximab
65
Palivizumab
64
Pandemic H1N1 and seasonal trivalent influenza VLP vaccines.
63
Anti Rho (D) immunoglobulin
62
Insulin API (r-DNA origin)
61
Salmonella typhi strain expressing HPV18 L1 and HPV16 L1 VLPs for Oral Vaccine
60
Chorionic Gonadotropin (rHCG)
59
B-type Natriuretic peptide (rhBNP, VB17)
58
BioChaperone 1 (PDGF-BB+DMCTrp)

 

YEAR 2009

57
Interferon gamma-1b (IFNg)
56
Parathyroid Hormone (rHu PTH)
55
Combination Malaria Vaccine Composed of Recombinant PfMSP-119 and PfF2
54
Darbepoetin-alpha
53
Etanercept (TNFr-antibody fusion protein)
52
Teriparatide (rDNA origin) Injection (750 mcg/vial)
51
Follicle Stimulating Hormone (rFSH)
50
Platelet Derived Growth Factor-BB (PDGF-BB)
49
Interleukin 2 (r-hu-IL-2)

 

YEAR 2008

48
Bevacizumab
47
Trastuzumab
46
Parathyroid Hormone (rhPTH1-34)
45
THR-100 (recombinant staphylokinase)
44
Hepatitis B antigen in novel formulation
43

Tetravalent vaccines (DPT+HEP-B)

42

Pegylated Human IFN alpha- 2b [PegIFN alpha2b]

41

Urate Oxidase (VB 37)

40
Anti Rabies Human Monoclonal Antibody (SII RMab)

 

YEAR 2007

39

G-CSF

38

Interferon beta 1b (rh-IFN- 1b)

37

G-CSF

36

Somatropin

35

Pegylated recombinant methionyl human Granulocyte Colony Stimulating Factor (PEG-r-met hu G-CSF)

34

rh-Tissue Plasminogen Activator (tPA)

33

Polysialated Erythropoietin

32

Darbopoetin

31

Nesiritide

30

Insulin Glargine

29

IN-105 (Oral insulin)

YEAR 2006

28

Tissue Plasminogen Activator (rh-TPA)

27

Pegylated r-h-erythropoietin

26

Pentavalent vaccine (Diphtheria, Tetanus, Pertusis, recombinant Hepatitis B and Haemophilus influenzae type B conjugate vaccine)

25

Rituximab (monoclonal antibody)

24

“BIOMAb EGFR” Humanized Anti-EGFR monoclonal antibody: Generic name Nimotuzumab injection) and Nimotuzumab-Bulk BIOMAb EGFR™-Bulk.

23

Monoclonal Tetanus Immunoglobulin

22

MAB RM1 IgGI.k

21

Granulocyte Colony Stimulating Factor (rh-G-CSF)

20

Hepatitis B antigen

19

Clinical evaluation of Relivax-DC for immunotherapy of prostate cancer

18

Tetravalent combination vaccine (DPT-r-Hepatitis B) and pantavalent combination vaccine (DPT-r-Hepatitis B + HIB)

17

Interferon alpha 2b (rh-IFNá2b)

16

Erythropoietin (rh-EPO)

YEAR 2005

15

Pegylated Granulocyte Colony Stimulating Factor (r-h-peg-G-CSF)

14

Lysostaphin gel

13

Granulocyte Colony Stimulating Factor (r-h-G-CSF)

12

streptokinase

11

Granulocyte-Macrophase Colony Stimulating Factor (r-hu-GM-CSF)

10

Pegylated Human Interferon Alfa 2b

9

Pentavalent combination vaccine consisting of Diphtheria, Tetanus, whole cell Pertussis, r-Hepatitis B & Hemophilus Influenzae type B (DTwPH-Hib)

8

TNK-t-PA

7

Follicle Stimulating Hormone (rh-FSH)

6

Interferon a2a

5

pegylated Interferon a2a

4

Interferon a2b

3

Pegylated Interferon a2b

2

Interferon alpha 2b (rh-IFN  2b)

1

Erythropoietin